Spark Therapeutics, Inc.
Spark Therapeutics, Inc. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Oct 30, 2025 · VAI
Newer recall under related name Foundation Medicine: Jun 10, 2026, Z-2951-2026.
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Foundation Medicine | 10 | 0 | 8 | 0 | Jun 10, 2026 (Z-2951-2026) |
| Ventana Medical Systems | 42 | 49 | 14 | 0 | Apr 20, 2026 (Z-2913-2026) |
| Roche Diagnostics Operations | 127 | 7 | 9 | 0 | Jan 20, 2026 (Z-1476-2026) |
| Genentech | 11 | 0 | 45 | 0 | May 20, 2024 (D-0509-2024) |
| Roche Diabetes Care | 29 | 13 | 2 | 0 | May 13, 2024 (Z-2174-2024) |
| Roche Molecular Systems | 42 | 55 | 26 | 0 | Dec 21, 2022 (Z-1106-2023) |
| Roche Diagnostics Corporation | 39 | 6 | 0 | 0 | Jun 3, 2019 (Z-1979-2019) |
| Roche Diagnostics | 0 | 457 | 24 | 0 | — |
| Hoffmann La Roche | 0 | 0 | 4 | 0 | — |
| Roche Pharma | 0 | 0 | 3 | 0 | — |
| Roche | 0 | 2 | 0 | 0 | — |
| Flatiron Health | 0 | 0 | 1 | 0 | — |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 30, 2025 | Philadelphia, PA | Biologics | Voluntary Action Indicated (VAI) | 3011194531 |
| Mar 4, 2022 | Philadelphia, PA | Biologics | No Action Indicated (NAI) | 3011194531 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3011194531 | Philadelphia, PA | 2 | Oct 30, 2025 |